Author: Eva Pastor
Date: 05-12-11 13:53
Source: MinnPost.com
URL: http://www.minnpost.com/learningcurve/2011
Date published: May 11th 2011
http://www.minnpost.com/learningcurve/2011/05/11/28201/u_of_m_dispute_over_research_ethics_morphs_into_academic_freedom_flap
U of M dispute over research ethics morphs into academic freedom flap
By Beth Hawkins | Published Wed, May 11 2011 9:35 am
You wouldn’t know it from reading local media, but in recent weeks the University of Minnesota has become Ground Zero in a high-stakes controversy over academic freedom. A number of faculty members have accused the administration of trying to silence a professor who has repeatedly drawn national attention to research protocols he charges are unethical.
It would appear that the simmering dispute is about to become a full-on conflagration.
Last fall, the magazine Mother Jones published a lengthy investigative article penned by Carl Elliott, a U of M bioethics professor and highly respected author of two books. The most recent, “White Coat, Black Hat: Adventures on the Dark Side of Medicine,” expands on the controversy.
A terrific, if horrifying, read, the Mother Jones story documents the 2003 death of a mentally ill man who was enrolled under questionable circumstances in a clinical trial at the U of the psychiatric drug Seroquel. The gist: Under pressure to find more participants for the lucrative trial, researchers enrolled Dan Markingson despite the fact that he had repeatedly threatened to kill his mother. Within six months, while he was still in the program, Markingson stabbed himself to death with a box cutter.
'$15,648 for each subject'
A taste:
“As a patient on public assistance, Dan's treatment would have normally generated little income for the university. Under its arrangement with AstraZeneca, however, the psychiatry department earned $15,648 for each subject who completed the CAFE study. ...
"In fact, during the months before Dan was enrolled, the department was apparently feeling pressure from [the contractor] that managed the study to step up recruitment. According to emails written by Jean Kenney, the university's study coordinator, the site had been placed on probation for its recruitment problems, and they were still 'struggling to get patients.' ...
"That began to change in April 2003, when the psychiatry department established a specialized inpatient unit at Fairview hospital called Station 12, in which every patient could be evaluated for research.”
After the piece was published a group of faculty members asked the university Board of Regents to order an independent investigation. In February, the regents declined.
(Lawmakers were more easily moved. Last year they passed a law banning researchers from enrolling certain mentally ill people in clinical trials.)
Enter the U's general counsel
A couple of weeks afterward, General Counsel Mark Rotenberg addressed the university’s Academic Freedom and Tenure Committee, seemingly suggesting that Elliott had defamed his colleagues. “What is the faculty[’s] collective role in addressing factually incorrect attacks on particular university faculty research activities?” he asked.
After reviewing the minutes of the meeting, still other faculty, including the president of the Minnesota chapter of the American Association of University Professors, decried Rotenberg’s question as inappropriate.
The “committee’s last meeting seemed to be presuming that the claims made against the researchers were false,” philosophy professor Naomi Scheman wrote to Elliott, according to Corporate Counsel magazine. “The committee cannot work on that highly prejudicial presumption. It is precisely what is at issue in the case.”
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